N
Patient 1
THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3057, SERIAL # UNKNOWN, PRODUCT TYPE SCREENING DEVICE.
MAUDE MDR 6383580
- MDR report key
- 6383580
- Report number
- 3007566237-2017-00871
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-02-08
- Date received
- 2017-03-07
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LISA CLARK
- Address
- 7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
- Phone
- 763-763-7635
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VERIFY | SELECTOR, SIZE, OSTOMY | MEDTRONIC NEUROMODULATION | EXA | 3531 | 3531 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-03-07 | 0 |
Event Narratives#
D
Patient 1
INFORMATION WAS RECEIVED FROM A CONSUMER?S FAMILY REGARDING A TRIAL PATIENT. IT WAS REPORTED THE STIM WAS TURNED OFF ON ITS OWN DURING THE NIGHT. IT WAS INDICATED THAT THERE WERE UNKNOWN ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS NOT RESOLVED AT TIME OF THE REPORT. A DAY LATER, IT WAS FURTHER REPORTED THAT PATIENT BROKE OFF HER LEAD DURING THE NIGHT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATION ASSOCIATED WITH THE EVENT. PATIENT STATUS WAS NOTED AS ALIVE, NO INJURY. PATIENT HAD BASIC EVALUATION TRIAL STARTED ON (B)(6) 2017.
N
Patient 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.